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Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant (GVHD)

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ClinicalTrials.gov Identifier: NCT00408681
Recruitment Status : Completed
First Posted : December 7, 2006
Results First Posted : January 20, 2017
Last Update Posted : March 7, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paul Martin, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Atypical Chronic Myeloid Leukemia, Breakpoint Cluster Region-abl Translocation (BCR-ABL) Negative
Blastic Phase Chronic Myelogenous Leukemia
Childhood Acute Lymphoblastic Leukemia in Remission
Childhood Acute Myeloid Leukemia in Remission
Childhood Chronic Myelogenous Leukemia
Childhood Myelodysplastic Syndromes
Chronic Eosinophilic Leukemia
Chronic Myelomonocytic Leukemia
Chronic Neutrophilic Leukemia
Chronic Phase Chronic Myelogenous Leukemia
de Novo Myelodysplastic Syndromes
Disseminated Neuroblastoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Gastrointestinal Complications
Juvenile Myelomonocytic Leukemia
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Nodal Marginal Zone B-cell Lymphoma
Noncontiguous Stage II Adult Burkitt Lymphoma
Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma
Noncontiguous Stage II Adult Lymphoblastic Lymphoma
Noncontiguous Stage II Grade 1 Follicular Lymphoma
Noncontiguous Stage II Grade 2 Follicular Lymphoma
Noncontiguous Stage II Grade 3 Follicular Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Noncontiguous Stage II Marginal Zone Lymphoma
Noncontiguous Stage II Small Lymphocytic Lymphoma
Poor Prognosis Metastatic Gestational Trophoblastic Tumor
Previously Treated Childhood Rhabdomyosarcoma
Primary Myelofibrosis
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Recurrent Childhood Large Cell Lymphoma
Recurrent Childhood Lymphoblastic Lymphoma
Recurrent Childhood Rhabdomyosarcoma
Recurrent Childhood Small Noncleaved Cell Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Malignant Testicular Germ Cell Tumor
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Neuroblastoma
Recurrent Ovarian Epithelial Cancer
Recurrent Ovarian Germ Cell Tumor
Recurrent Small Lymphocytic Lymphoma
Recurrent Wilms Tumor and Other Childhood Kidney Tumors
Recurrent/Refractory Childhood Hodgkin Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Hairy Cell Leukemia
Relapsing Chronic Myelogenous Leukemia
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Splenic Marginal Zone Lymphoma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage II Ovarian Epithelial Cancer
Stage III Adult Burkitt Lymphoma
Stage III Adult Diffuse Large Cell Lymphoma
Stage III Adult Diffuse Mixed Cell Lymphoma
Stage III Adult Diffuse Small Cleaved Cell Lymphoma
Stage III Adult Hodgkin Lymphoma
Stage III Adult Immunoblastic Large Cell Lymphoma
Stage III Adult Lymphoblastic Lymphoma
Stage III Chronic Lymphocytic Leukemia
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage III Grade 3 Follicular Lymphoma
Stage III Malignant Testicular Germ Cell Tumor
Stage III Mantle Cell Lymphoma
Stage III Marginal Zone Lymphoma
Stage III Multiple Myeloma
Stage III Ovarian Epithelial Cancer
Stage III Small Lymphocytic Lymphoma
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Adult Burkitt Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Stage IV Adult Diffuse Mixed Cell Lymphoma
Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
Stage IV Adult Hodgkin Lymphoma
Stage IV Adult Immunoblastic Large Cell Lymphoma
Stage IV Adult Lymphoblastic Lymphoma
Stage IV Breast Cancer
Stage IV Chronic Lymphocytic Leukemia
Stage IV Grade 1 Follicular Lymphoma
Stage IV Grade 2 Follicular Lymphoma
Stage IV Grade 3 Follicular Lymphoma
Stage IV Mantle Cell Lymphoma
Stage IV Marginal Zone Lymphoma
Stage IV Ovarian Epithelial Cancer
Stage IV Small Lymphocytic Lymphoma
Interventions Drug: lithium carbonate
Other: laboratory biomarker analysis
Enrollment 20
Recruitment Details Patients with severe gastrointestinal acute graft-versus-host disease with or without mucosal denudation identified by endoscopy were recruited from a hospitalized population of patients who had recent allogeneic hematopoietic cell transplantation.
Pre-assignment Details Patients were enrolled according to eligibility criteria in the protocol.
Arm/Group Title Treated Patients
Hide Arm/Group Description Patients receive oral lithium carbonate once or twice daily orally. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 20
Completed 11 [1]
Not Completed 9
Reason Not Completed
Lack of Efficacy             2
Adverse Event             7
[1]
Completion was defined as administration of the study product for at least 28 days.
Arm/Group Title Treated Patients
Hide Arm/Group Description Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
49.5
(22 to 63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
13
  65.0%
Male
7
  35.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
1
   5.0%
Not Hispanic or Latino
19
  95.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   5.0%
Native Hawaiian or Other Pacific Islander
1
   5.0%
Black or African American
1
   5.0%
White
14
  70.0%
More than one race
2
  10.0%
Unknown or Not Reported
1
   5.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
 100.0%
Indication for transplantation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Non-Hodgkin lymphoma
3
  15.0%
Acute myeloid leukemia
6
  30.0%
Multiple myeloma
2
  10.0%
Chronic myeloid leukemia
2
  10.0%
Acute lymphoid leukemia
3
  15.0%
Myelodysplastic syndrome
1
   5.0%
Aplastic anemia
1
   5.0%
Paroxysmal nocturnal hemoglobinuria
1
   5.0%
Chronic lymphocytic leukemia
1
   5.0%
Type of pretransplant conditioning regimen  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Myeloablative
12
  60.0%
Nonmyeloablative
8
  40.0%
Graft-versus-host disease (GVHD) prophylaxis regimen  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Cyclosporine and mycophenolate mofetil (MMF)
8
  40.0%
Tacrolimus and methotrexate
10
  50.0%
Cyclophosphamide, tacrolimus, MMF
1
   5.0%
Tacrolimus and mycophenolate mofeftil
1
   5.0%
Mucosal denudation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Duodenum alone
7
  35.0%
Colon alone
7
  35.0%
Duodenum and colon
3
  15.0%
Agents given to prevent GVHD at the time of enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Tacrolimus
8
  40.0%
Cyclosporine
7
  35.0%
Mycophenolate mofetil
8
  40.0%
Agents given to treat GVHD more than 3 days before enrollment in the study  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Infliximab
3
  15.0%
Rabbit anti-thymocyte globulin
3
  15.0%
Horse anti-thymocyte globulin
1
   5.0%
Extracorporeal photopheresis
2
  10.0%
Mesenchymal stem cells
1
   5.0%
Mycophenolate mofetil
5
  25.0%
Tacrolimus
3
  15.0%
Sirolimus
1
   5.0%
Cyclosporine
1
   5.0%
Interval from transplantation to start of study product administration  
Median (Full Range)
Unit of measure:  Days
Number Analyzed 20 participants
90
(22 to 215)
Agents given to treat GVHD within 3 days before or after enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Methotrexate
1
   5.0%
Pentostatin
2
  10.0%
Rabbit anti-thymocyte globulin
4
  20.0%
Mycophenolate mofetil
1
   5.0%
Infliximab
2
  10.0%
Alemtuzumab
1
   5.0%
1.Primary Outcome
Title Functional Recovery
Hide Description Functional recovery was defined as partial or complete resolution of gastrointestinal manifestations of acute graft-versus-host disease. Gastrointestinal manifestations of acute graft-versus-host disease include anorexia, nausea, vomiting, diarrhea, abdominal pain and bleeding. Complete response (CR) of intestinal GVHD was defined as the absence of any symptoms referable to intestinal GVHD. Partial response (PR) was defined as clearing of abdominal pain (or withdrawal of opioid analgesic requirements in patients treated for abdominal pain) and of grossly visible bleeding if present, and resolution of diarrhea or decrease in the three day average stool volume by ≥ 500 mL in patients with stool volumes of ≥ 500 mL. Progression of GVHD was defined as an increase in the three day average stool volume by > 500 mL, or the development of new abdominal pain (or new opioid analgesic requirements) or new intestinal bleeding.
Time Frame at 28 days after starting treatment with the study product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treated Patients
Hide Arm/Group Description:
Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
Complete clinical response
10
  50.0%
Partial clinical response
1
   5.0%
No response or clinical progression
6
  30.0%
Death before day 28
3
  15.0%
2.Secondary Outcome
Title Duration of Treatment With the Study Product
Hide Description Number of days from beginning of orally administered lithium carbonate to the end of orally administered lithium carbonate
Time Frame Up to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treated Patients
Hide Arm/Group Description:
Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: days
30.5
(7 to 172)
3.Secondary Outcome
Title Mucosal Anatomic Recovery
Hide Description Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.
Time Frame 2 to 3 weeks after starting treatment with the study product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 8 of the 20 enrolled patients had endoscopic evaluation during this time window.
Arm/Group Title Treated Patients
Hide Arm/Group Description:
Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
No improvement
3
  37.5%
Regenerative changes
3
  37.5%
Partial improvement
2
  25.0%
4.Secondary Outcome
Title Mucosal Anatomic Recovery
Hide Description Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.
Time Frame 4 weeks after starting treatment with the study product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 2 patients had endoscopic evaluation during this time window.
Arm/Group Title Treated Patients
Hide Arm/Group Description:
Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
Limited improvement
1
  50.0%
Partial improvement
1
  50.0%
5.Secondary Outcome
Title Mucosal Anatomic Recovery
Hide Description Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.
Time Frame 5 weeks after starting treatment with the study product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 1 patient had endoscopic evaluation during this time window.
Arm/Group Title Treated Patients
Hide Arm/Group Description:
Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
Partial improvement
1
 100.0%
Complete response
0
   0.0%
6.Secondary Outcome
Title Mucosal Anatomic Recovery
Hide Description Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.
Time Frame 6 to 7 weeks after starting treatment with the study product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 3 patients had endoscopic evaluation during this time window.
Arm/Group Title Treated Patients
Hide Arm/Group Description:
Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
Partial improvement
0
   0.0%
Complete response
3
 100.0%
7.Secondary Outcome
Title Mucosal Anatomic Recovery
Hide Description Endoscopic evaluation of improvement. Categories include 1) no improvement, 2) regenerative changes, 3) limited improvement, 4) partial improvement and 5) complete response. Endoscopic manifestations of acute graft-versus-host disease include edema, erythema, mucosal ulceration and denudation. Complete mucosal recovery was defined as the appearance of intact mucosa with at least 98% of the luminal surface covered by epithelium. Partial response was defined as the appearance of mostly intact mucosa with at least 80% improvement or less than 10% denuded. Limited response was retrospectively designated to describe visible improvement that was less than partial response. Regenerative change was retrospectively designated to describe early reappearance of mucosal integrity in a previously denuded area but not sufficient to meet criteria for partial response. Failure to respond was defined as failure to meet partial response criteria.
Time Frame 9 to 11 weeks after starting treatment with the study product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 4 patients had endoscopic evaluation during this time window.
Arm/Group Title Treated Patients
Hide Arm/Group Description:
Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
Partial improvement
2
  50.0%
Complete response
2
  50.0%
8.Secondary Outcome
Title Recurrent or Progressive Malignancy
Hide Description Recurrence or progression of the malignant disease that was the reason for hematopoietic cell transplantation
Time Frame 2 years after enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treated Patients
Hide Arm/Group Description:
Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.0%
9.Secondary Outcome
Title Non-relapse Mortality
Hide Description Death without prior recurrent or progressive malignancy after transplantation.
Time Frame 2 years after enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treated Patients
Hide Arm/Group Description:
Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
13
  65.0%
10.Secondary Outcome
Title Survival
Hide Description Patients who were alive at the specified time after enrollment
Time Frame 6 months after enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treated Patients
Hide Arm/Group Description:
Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
10
  50.0%
11.Secondary Outcome
Title Survival
Hide Description Patients who were alive at the specified time point
Time Frame 1 year after enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treated Patients
Hide Arm/Group Description:
Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
8
  40.0%
12.Secondary Outcome
Title Survival
Hide Description Patients who were alive at the specified time point
Time Frame 2 years after enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:
Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
7
  35.0%
13.Secondary Outcome
Title Causes of Death
Hide Description Medical condition that made the greatest contribution in causing death
Time Frame up to 6 years after enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treated Patients
Hide Arm/Group Description:
Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
Recurrent or progressive malignancy
2
  10.0%
Acute graft-versus-host disease
11
  55.0%
Chronic GVHD with bronchiolitis obliterans
2
  10.0%
Infection
7
  35.0%
Multiorgan failure
2
  10.0%
Diffuse alveolar hemorrhage
1
   5.0%
Hemolytic uremic syndrome
1
   5.0%
14.Other Pre-specified Outcome
Title Agents Added to Treat GVHD More Than 3 Days After Enrollment
Hide Description Any systemic medication given in an effort to control graft-versus-host disease
Time Frame Up to 100 days after enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treated Patients
Hide Arm/Group Description:
Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
Methotrexate
1
   5.0%
Pentostatin
1
   5.0%
Rabbit anti-thymocyte globulin
5
  25.0%
Mycophenolate mofetil
4
  20.0%
Tacrolimus
2
  10.0%
Infliximab
4
  20.0%
Etanercept
1
   5.0%
Alemtuzumab
1
   5.0%
Sirolimus
6
  30.0%
Time Frame Up to 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treated Patients
Hide Arm/Group Description Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Treated Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treated Patients
Affected / at Risk (%)
Total   12/20 (60.00%) 
Blood and lymphatic system disorders   
Recurrent malignancy *  1/20 (5.00%) 
Immune system disorders   
Graft-versus-host disease *  7/20 (35.00%) 
Infections and infestations   
Infection *  7/20 (35.00%) 
Nervous system disorders   
Altered mental status *  2/20 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
Diffuse alveolar hemorrhage *  1/20 (5.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treated Patients
Affected / at Risk (%)
Total   11/20 (55.00%) 
Blood and lymphatic system disorders   
Leukocytosis *  1/20 (5.00%) 
Gastrointestinal disorders   
Nausea or vomiting *  2/20 (10.00%) 
Nervous system disorders   
Somnolence or fatigue *  6/20 (30.00%) 
Confusion *  3/20 (15.00%) 
Renal and urinary disorders   
Polyuria *  1/20 (5.00%) 
*
Indicates events were collected by non-systematic assessment
This trial was not controlled in any scientifically valid sense of the term. Clinical management included many changes of treatment other than the use of the study product. The trial had no validated external benchmark for comparisons.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Paul J. Martin, M.D.
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-667-4798
Responsible Party: Paul Martin, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00408681     History of Changes
Other Study ID Numbers: 2080.00
NCI-2010-00269
First Submitted: December 6, 2006
First Posted: December 7, 2006
Results First Submitted: November 23, 2016
Results First Posted: January 20, 2017
Last Update Posted: March 7, 2017